Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy

NACompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

September 1, 2022

Study Completion Date

September 1, 2022

Conditions
Diabetic Neuropathies
Interventions
OTHER

Physical therapy by foot-ankle segmental and functional exercises

The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.

Trial Locations (1)

05360-160

Universidade de São Paulo, São Paulo

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

University of Sao Paulo General Hospital

OTHER

NCT04011267 - Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy | Biotech Hunter | Biotech Hunter